18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE PROXIMAL HUMERAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496033806·PERSONALITY 140 SHEER, SIZE 1XXL, GLACE, GRADUA...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033806·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position
SYNTHES METALLIC SPIKED WASHERS
FDA 510(k)
FDA Class 2
·Orthopedic
URETEROSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 23, 2006
BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 17, 2022
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 20, 2006
PORTASCAN
FDA Adverse Event
Malfunction
·MEDIWATCH UK LTD·Product code ITX·November 17, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 3, 2013
PARADYM
FDA Adverse Event
Malfunction
·SORIN CRM S.R.L.·Product code MRM·February 11, 2011
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 24, 2008
BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 2, 2023
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTO·April 19, 2005
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024